Active substance
Bendamustine
- SFDA 12
- US FDA 20
- Health Canada 11
- WHO EML 1
- Safety 9
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| BENDAMUSTINE-VENUS | 100 mg | Lyophilisate for solution for injection · Intravenous use | 1 Vial | SAR 831.50 | Generic · Prescription | VENUS REMEDIES LIMITED | Valid |
| Bedamuse | 25 mg | Powder for concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 1039.40 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| Bedamuse | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 4157.60 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| Bendokey | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 900.80 | Generic · Prescription | Eugia Pharma Specialities Limited | Valid |
| Bindolent | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 831.50 | Generic · Prescription | Seacross Pharmaceuticals Ltd | Valid |
| Bindolent | 25 mg | Powder for concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 1039.40 | Generic · Prescription | Seacross Pharmaceuticals Ltd | Valid |
| Ensutine | 45 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 1257.25 | Generic · Prescription | SUDAIR PHARMA COMPANY | Valid |
| RIBOMUSTIN 100 mg powder for concentrate for solution for infusion | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 5196.75 | NCE · Prescription | ASTELLAS PHARMA | Valid |
| RIBOMUSTIN 100 mg powder for concentrate for solution for infusion | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 1039.35 | NCE · Prescription | ASTELLAS PHARMA | Valid |
| RIBOMUSTIN 25 mg powder for concentrate for solution for infusion | 25 mg | Powder for concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 1299.25 | NCE · Prescription | ASTELLAS PHARMA | Valid |
| Squadaion | 25 mg | Lyophilisate for solution for injection · Intravenous use | 1 Vial | SAR 242.50 | Generic · Prescription | Mylan Laboratories Limited | Valid |
| Squadaion | 100 mg | Lyophilisate for solution for injection · Intravenous use | 1 Vial | SAR 970.10 | Generic · Prescription | Mylan Laboratories Limited | Valid |
Indications — CHI Daman Drug Formulary
AMYLOIDOSIS - LIGHT CHAIN; LYMPHOPLASMACYTIC LYMPHOMA; MULTIPLE MYELOMA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TREANDA | 100MG/VIAL; 25MG/VIAL | powder · intravenous | CEPHALON | Prescription | 20 Mar 2008 |
| TREANDA | 100MG | injectable · injection | CEPHALON | Prescription | 31 Oct 2008 |
| BENDEKA | 100MG/4ML (25MG/ML) | solution · intravenous | EAGLE PHARMS | Prescription | 7 Dec 2015 |
| BELRAPZO | 100MG/4ML (25MG/ML) | solution · intravenous | EAGLE PHARMS | Prescription | 15 May 2018 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · intravenous | DR REDDYS | Prescription | 7 Dec 2022 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · intravenous | ACCORD HLTHCARE | Prescription | 7 Dec 2022 |
| VIVIMUSTA | 100MG/4ML (25MG/ML) | solution · intravenous | AZURITY | Prescription | 7 Dec 2022 |
| BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | solution · intravenous | APOTEX | Prescription | 7 Dec 2022 |
| BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | solution · intravenous | BAXTER HLTHCARE CORP | Prescription | 15 Dec 2022 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · intravenous | MEITHEAL | Prescription | 5 Jun 2023 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · intravenous | EUGIA PHARMA | Prescription | 5 Jun 2023 |
| BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | solution · intravenous | AVYXA HOLDINGS | Prescription | 3 Jul 2025 |
| TREANDA | 45MG/0.5ML (90MG/ML); 180MG/2ML (90MG/ML) | solution · intravenous | CEPHALON | Discontinued | 20 Mar 2008 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML); 100MG/4ML (25MG/ML); 200MG/8ML (25MG/ML) | solution · intravenous | HOSPIRA | Discontinued | 15 Dec 2022 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · intravenous | BRECKENRIDGE | Discontinued | 14 Feb 2023 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · intravenous | PHARMOBEDIENT | Discontinued | 28 Apr 2023 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · intravenous | APOTEX | Discontinued | 5 Jun 2023 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · intravenous | NANG KUANG PHARM CO | Discontinued | 7 Jun 2023 |
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · iv (infusion) | Discontinued | ||
| BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL; 100MG/VIAL | powder · iv (infusion) | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | 02496852 | 25 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | ACCORD HEALTHCARE INC |
| BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | 02496860 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | ACCORD HEALTHCARE INC |
| BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | 02509253 | 25 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | AURO PHARMA INC |
| BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | 02509261 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | AURO PHARMA INC |
| BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | 02541998 | 25 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | EUGIA PHARMA INC. |
| BENDAMUSTINE HYDROCHLORIDE FOR INJECTION | 02542005 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | EUGIA PHARMA INC. |
| BENVYON | 02524309 | 25 MG / ML | SOLUTION · INTRAVENOUS | PFIZER CANADA ULC |
| NAT-BENDAMUSTINE | 02496887 | 25 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | NATCO PHARMA (CANADA) INC |
| NAT-BENDAMUSTINE | 02496895 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | NATCO PHARMA (CANADA) INC |
| TREANDA | 02392550 | 25 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | TEVA CANADA LIMITED |
| TREANDA | 02392569 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | TEVA CANADA LIMITED |
WHO WHO Model List of Essential Medicines (2025)
- 8.2.1. Cytotoxic medicines · complementary
Chronic lymphocytic leukaemia or small lymphocytic lymphoma; Follicular lymphoma
Parenteral > General injections > unspecified: 45 mg per 0.5 mL; 180 mg per 2 mL
Safety signals and safety-related labeling changes
- US FDA 15 Apr 2024 BENDAMUSTINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 27 Feb 2024 VIVIMUSTA — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 26 Feb 2024 BENDAMUSTINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 25 Jan 2024 BENDAMUSTINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 11 Jan 2024 BELRAPZO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 11 Jan 2024 BENDEKA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 25 Oct 2022 TREANDA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 24 Mar 2021 Bendamustine (Levact): increased risk of non-melanoma skin cancer and progressive multifocal encephalopathy (PML)
Periodically perform skin examinations in patients on bendamustine-containing regimens and consider PML in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural signs or symptoms. - MHRA 20 Jul 2017 Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation
Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications. Be aware that the risk of opportunistic infections for all patients receiving bendamustine including those receiving off-label treatment may be greater than previously recognised. Be aware of your responsibilities if prescribing bendamustine outside the licensed indications.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.